The Galleri® Community Research Program

GRAIL, Inc.

Status: Invitation-only

Conditions: Data Collection

Study type: Observational

Funder types: Industry

Identifiers

NCT06603259

GRAIL-MA-003

Details and patient eligibility

About

GRAIL, the company that developed the Galleri test and is sponsoring this study, would like to learn more from individuals who have received the Galleri multi-cancer early detection test.

The purpose of this study is to understand how health information can be accurately collected from the medical records of individuals who have received the Galleri test in a real world setting. The collected information may include relevant medical and cancer history, diagnostic test results, including the Galleri test result. This will help GRAIL build a future larger study for individuals who have taken the Galleri test. This future study is important for understanding patient journeys after a Galleri test (including any diagnostic testing done and any diagnoses made), for improving the Galleri test, and to contribute to other research on cancer screening.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have received the Galleri test prescribed by a provider per clinical care
• Capable of giving signed and legally effective informed consent. Consent provided by a legally authorized representative is not permitted in this protocol.
• Have signed HIPAA authorization(s)* form for their medical records to be released and used for this study.

Exclusion criteria

• Patients are excluded from the study if the patient is a GRAIL employee or contractor.
• Patients who have received the Galleri test in a GRAIL-sponsored research setting (i.e., clinical trial) are excluded.